scholarly journals Regulatory standards and processes for over-the-counter availability of hormonal contraception and drugs for medical abortion in five countries in the Eastern Mediterranean Region

2021 ◽  
Vol 19 (S1) ◽  
Author(s):  
Anne Ammerdorffer ◽  
Mark Laws ◽  
Arinze Awiligwe ◽  
Florence Erb ◽  
Wallada Im-Amornphong ◽  
...  

AbstractThe World Health Organization 2019 WHO consolidated guideline on self-care interventions for health: sexual and reproductive health and rights includes recommendations on self-administration of injectable contraception, over-the-counter (OTC) oral contraception and self-management of medical abortion. A review of the regulatory status of these two self-care interventions can highlight processes required to ensure that the quality of the medicines and safety of individuals are safeguarded in the introduction and scale-up in countries. This review outlines the legal regulatory status of prescription-only medicine (POM) and OTC contraceptives, including emergency contraception, and drugs for medical abortion in Egypt, Jordan, Lebanon, Morocco and Tunisia using information obtained from internet searches, regulatory information databases and personal contacts. In addition, the review examines whether the national medicines regulatory authorities have documented procedures available to allow for a change in status from a POM to OTC to allow for increased accessibility, availability and uptake of self-care interventions recommended by WHO. Egypt, Jordan and Lebanon have a documented national OTC list available. The only contraceptive product mentioned in the OTC lists across all five countries is ellaOne (ulipristal acetate for emergency contraception), which is publicly registered in Lebanon. None of the five countries has an official documented procedure to apply for the change of POM to OTC. Informal procedures exist, such as the ability to apply to the national medicines regulatory authority for OTC status if the product has OTC status in the original country of manufacture. However, many of these procedures are not officially documented, highlighting the need for establishing sound, affordable and effective regulation of medical products as an important part of health system strengthening. From a public health perspective, it would be advantageous for licensed products to be available OTC. This is particularly the case for settings where the health system is under-resourced or over-stretched due to health emergencies. Readiness of national regulatory guidelines and OTC procedures could lead to increased access, availability and usage of essential self-care interventions for sexual and reproductive health and rights.

2020 ◽  
Vol 14 (1) ◽  
Author(s):  
Nguyen Toan Tran ◽  
Alison Greer ◽  
Brigitte Kini ◽  
Hassan Abdi ◽  
Kariman Rajeh ◽  
...  

Abstract Background Planning to transition from the Minimum Initial Service Package for Sexual and Reproductive Health (SRH) toward comprehensive SRH services has been a challenge in humanitarian settings. To bridge this gap, a workshop toolkit for SRH coordinators was designed to support effective planning. This article aims to describe the toolkit design, piloting, and final product. Methods Anchored in the Health System Building Blocks Framework of the World Health Organization, the design entailed two complementary and participatory strategies. First, a collaborative design phase with iterative feedback loops involved global partners with extensive operational experience in the initial toolkit conception. The second phase engaged stakeholders from three major humanitarian crises to participate in pilot workshops to contextualize, evaluate, validate, and improve the toolkit using qualitative interviews and end-of-workshop evaluations. The aim of this two-phase design process was to finalize a planning toolkit that can be utilized in and adapted to diverse humanitarian contexts, and efficiently and effectively meet its objectives. Pilots occurred in the Democratic Republic of Congo for the Kasai region crisis, Bangladesh for the Rohingya humanitarian response in Cox’s Bazar, and Yemen for selected Governorates. Results Results suggest that the toolkit enabled facilitators to foster a systematic, participatory, interactive, and inclusive planning process among participants over a two-day workshop. The approach was reportedly effective and time-efficient in producing a joint work plan. The main planning priorities cutting across settings included improving comprehensive SRH services in general, healthcare workforce strengthening, such as midwifery capacity development, increasing community mobilization and engagement, focusing on adolescent SRH, and enhancing maternal and newborn health services in terms of quality, coverage, and referral pathways. Recommendations for improvement included a dedicated and adequately anticipated pre-workshop preparation to gather relevant data, encouraging participants to undertake preliminary study to equalize knowledge to partake fully in the workshop, and enlisting participants from marginalized and underserved populations. Conclusion Collaborative design and piloting efforts resulted in a workshop toolkit that could support a systematic and efficient identification of priority activities and services related to comprehensive SRH. Such priorities could help meet the SRH needs of communities emerging from acute humanitarian situations while strengthening the overall health system.


2020 ◽  
Author(s):  
Nguyen Toan Tran ◽  
Alison Greer ◽  
Brigitte Kini ◽  
Hassan Abdi ◽  
Kariman Rajeh ◽  
...  

Abstract BackgroundPlanning to transition from the Minimum Initial Service Package for Sexual and Reproductive Health (SRH) toward comprehensive SRH services has been a challenge in humanitarian settings. To bridge this gap, a workshop toolkit for SRH coordinators was designed to support effective planning. This article aims to describe the toolkit design, piloting, and final product.MethodsAnchored in the Health System Building Blocks Framework of the World Health Organization, the design entailed two complementary and participatory strategies. First, a collaborative design phase with iterative feedback loops involved global partners with extensive operational experience in the initial toolkit conception. The second phase engaged stakeholders from three major humanitarian crises to participate in pilot workshops to contextualize, evaluate, validate, and improve the toolkit using qualitative interviews and end-of-workshop evaluations. The aim of this two-phase design process was to finalize a planning toolkit that can be utilized in and adapted to diverse humanitarian contexts, and efficiently and effectively meet its objectives. Pilots occurred in the Democratic Republic of Congo for the Kasai region crisis, Bangladesh for the Rohingya humanitarian response in Cox’s Bazar, and Yemen for selected Governorates.ResultsResults suggest that the toolkit enabled facilitators to foster a systematic, participatory, interactive, and inclusive planning process among participants over a two-day workshop. The approach was reportedly effective and time-efficient in producing a joint work plan. The main planning priorities cutting across settings included improving comprehensive SRH services in general, healthcare workforce strengthening, such as midwifery capacity development, increasing community mobilization and engagement, focusing on adolescent SRH, and enhancing maternal and newborn health services in terms of quality, coverage, and referral pathways. Recommendations for improvement included a dedicated and adequately anticipated pre-workshop preparation to gather relevant data, encouraging participants to undertake preliminary study to equalize knowledge to partake fully in the workshop, and enlisting participants from marginalized and underserved populations.ConclusionCollaborative design and piloting efforts resulted in a workshop toolkit that could support a systematic and efficient identification of priority activities and services related to comprehensive SRH. Such priorities could help meet the SRH needs of communities emerging from acute humanitarian situations while strengthening the overall health system.


2020 ◽  
Author(s):  
Nguyen Toan Tran ◽  
Alison Greer ◽  
Brigitte Kini ◽  
Hassan Abdi ◽  
Kariman Rajeh ◽  
...  

Abstract BackgroundPlanning to transition from the Minimum Initial Service Package for Sexual and Reproductive Health (SRH) toward comprehensive SRH services has been a challenge in humanitarian settings. To bridge this gap, a workshop toolkit for SRH coordinators was designed to support effective planning. This article aims to describe the toolkit design, piloting, and final product.MethodsAnchored in the Health System Building Blocks Framework of the World Health Organization, the design entailed two complementary and participatory strategies. First, a collaborative design phase with iterative feedback loops involved global partners with extensive operational experience in the initial toolkit conception. The second phase engaged stakeholders from three major humanitarian crises to participate in pilot workshops to contextualize, evaluate, validate, and improve the toolkit using qualitative interviews and end-of-workshop evaluations. The aim of this two-phase design process was to finalize a planning toolkit that can be utilized in and adapted to diverse humanitarian contexts, and efficiently and effectively meet its objectives. Pilots occurred in the Democratic Republic of Congo for the Kasai region crisis, Bangladesh for the Rohingya humanitarian response in Cox’s Bazar, and Yemen for selected Governorates.ResultsResults suggest that the toolkit enabled facilitators to foster a systematic, participatory, interactive, and inclusive planning process among participants over a two-day workshop. The approach was reportedly effective and time-efficient in producing a joint work plan. The main planning priorities cutting across settings included improving comprehensive SRH services in general, healthcare workforce strengthening, such as midwifery capacity development, increasing community mobilization and engagement, focusing on adolescent SRH, and enhancing maternal and newborn health services in terms of quality, coverage, and referral pathways. Recommendations for improvement included a dedicated and adequately anticipated pre-workshop preparation to gather relevant data, encouraging participants to undertake preliminary study to equalize knowledge to partake fully in the workshop, and enlisting participants from marginalized and underserved populations.ConclusionCollaborative design and piloting efforts resulted in a workshop toolkit that could support a systematic and efficient identification of priority activities and services related to comprehensive SRH. Such priorities could help meet the SRH needs of communities emerging from acute humanitarian situations while strengthening the overall health system.


2020 ◽  
Author(s):  
Nguyen Toan Tran ◽  
Alison Greer ◽  
Brigitte Kini ◽  
Hassan Abdi ◽  
Kariman Rajeh ◽  
...  

Abstract BackgroundPlanning to transition from the Minimum Initial Service Package for Sexual and Reproductive Health (SRH) toward comprehensive SRH services has been a challenge in humanitarian settings. To bridge this gap, a workshop toolkit for SRH coordinators was designed to support effective planning. This article aims to describe the toolkit design, piloting, and final product. MethodsAnchored in the WHO Health System Building Blocks Framework, the design entailed two complementary strategies. First, a circular approach involved global partners in the initial toolkit conception. Second, a bottom-up approach engaged field stakeholders from three major humanitarian crises to participate in pilot workshops to evaluate and improve the toolkit using qualitative interviews and end-of-workshop evaluations. Pilots occurred in DR Congo for the Kasai region crisis, Bangladesh for the Rohingya humanitarian response in Cox’s Bazar, and Yemen for selected Governorates.ResultsResults suggest that the toolkit enabled facilitators to foster a systematic, participatory, interactive, and inclusive planning process among participants over a two-day workshop. The approach was reportedly effective and time-efficient in producing a joint work plan. The main planning priorities cutting across settings were healthcare workforce strengthening, such as midwifery capacity development, increasing community mobilization and engagement, focusing on adolescent SRH, and enhancing maternal and newborn health services in terms of quality, coverage, and referral pathways. Recommendations for improvement included a dedicated and adequately anticipated pre-workshop preparation to gather relevant data, encouraging participants to undertake preliminary study to equalize knowledge to partake fully in the workshop, and enlisting participants from marginalized and underserved populations. ConclusionCollaborative design and piloting efforts resulted in a workshop toolkit that could support a systematic and efficient identification of priority activities and services related to comprehensive SRH. Such priorities could help meet the SRH needs of communities emerging from acute humanitarian situations while strengthening the overall health system.


Pharmacy ◽  
2021 ◽  
Vol 9 (3) ◽  
pp. 132
Author(s):  
Lezley-Anne Hanna ◽  
Alana Murphy ◽  
Maurice Hall ◽  
Rebecca Craig

Background: The aim was to investigate pharmacy students’ views on the role of the pharmacist in facilitating self-care with over-the-counter (OTC) medicines, particularly in light of new roles, and establish personal practice. Methods: Final year pharmacy students at Queen’s University Belfast were invited to participate. Data were collected via a pre-piloted questionnaire, distributed at a compulsory class (only non-identifiable data were requested). Descriptive statistics were performed, and non-parametric tests were employed for inferential statistical analysis (responses by gender). Results: The response rate was 87.6% (78/89); 34.6% (27/78) males and 65.4% (51/78) females. Over a third [34.6% (27/78)] reported using OTC medicines about once a month. All appreciated the importance of an evidence-based approach to optimize patient care. Most [(96.2% (75/78)] deemed OTC consultations should remain a fundamental responsibility of pharmacists and 69.2% (54/78) thought OTC consultations have the potential to be as complex as independent pharmacist prescribing. Females felt more confident recommending OTC emergency contraception than males (p = 0.002 for levonorgestrel and p = 0.011 for ulipristal acetate). Many [61.5% (48/78)] considered more medicines should not be deregulated from prescription-only status. Conclusions: Data from this single institution suggests that enabling self-medication is an important part of practice but there were confidence issues around deregulations.


2021 ◽  
Vol 19 (S1) ◽  
Author(s):  
Qudsia Uzma ◽  
Nausheen Hamid ◽  
Rizwana Chaudhri ◽  
Nadeem Mehmood ◽  
Atiya Aabroo ◽  
...  

Abstract Background Pakistan is among a number of countries facing protracted challenges in addressing maternal mortality with a concomitant weak healthcare system complexed with inequities. Sexual and reproductive health and rights (SRHR) self-care interventions offer the best solution for improving access to quality healthcare services with efficiency and economy. This manuscript documents country experience in introducing and scaling up two selected SRHR self-care interventions. A prospective qualitative study design was used and a semi-structured questionnaire was shared with identified SRHR private sector partners selected through convenience and purposive sampling. The two interventions include the use of misoprostol for postpartum hemorrhage and the use of subcutaneous depomedroxyprogesterone acetate (DMPA) as injectable contraceptive method. Data collection was done through emails and telephone follow-up calls. Results Nine of the 13 partners consulted for the study responded. The two selected self-care interventions are mainly supported by private sector partners (national and international nongovernmental organizations) having national or subnational existence. Their mandates include all relevant areas, such as policy advocacy, field implementation, trainings, supervision and monitoring. A majority of partners reported experience related to the use of misoprostol; it was introduced more than a decade ago, is registered and is procured by both public and private sectors. Subcutaneous DMPA is a new intervention, having been introduced only recently, and commodity availability remains a challenge. It is being delivered through health workers/providers and is not promoted as a self-administered contraceptive. Community engagement and awareness raising is reported as an essential element of successful field implementation; however, no beneficiary data was collected for the study. Training approaches differ considerably, are standalone or integrated with SRHR topics and their duration varies between 1 and 5 days, covering a range of cadres. Conclusion Pubic sector ownership and patronage is essential for introducing and scaling up self-care interventions as a measure to support the healthcare system in delivering quality sexual and reproductive health services. Supervision, monitoring and reporting are areas requiring further support, as well as the leadership and governance role of the public sector. Standardization of trainings, community awareness, supervision, monitoring and reporting are required together with integration of self-care in routine capacity building activities (pre- and in-service) on sexual and reproductive health in the country.


2021 ◽  
Vol 19 (1) ◽  
Author(s):  
Manjulaa Narasimhan ◽  
Carmen H. Logie ◽  
Kevin Moody ◽  
Jonathan Hopkins ◽  
Oswaldo Montoya ◽  
...  

Abstract Background Self-care interventions are influencing people’s access to, expectation and understanding of healthcare beyond formal health delivery systems. In doing so, self-care interventions could potentially improve health-seeking behaviours. While many men proactively engage in maintaining and promoting their health, the focus on men’s health comes from the recognition, at least partially, that male socialization and social norms can induce men and boys to have a lower engagement in institutionalized public health entities and systems around their sexual and reproductive health and rights, that could impact negatively on themselves, their partners and children. Main text A research agenda could consider the ways that public health messaging and information on self care practices for sexual and reproductive health and rights could be tailored to reflect men’s lived realities and experiences. Three examples of evidence-based self-care interventions related to sexual and reproductive health and rights that men can, and many do, engage in are briefly discussed: condom use, HIV self-testing and use of telemedicine and digital platforms for sexual health. We apply four core elements that contribute to health, including men’s health (people-centred approaches, quality health systems, a safe and supportive enabling environment, and behaviour-change communication) to each intervention where further research can inform normative guidance. Conclusion Engaging men and boys and facilitating their participation in self care can be an important policy intervention to advance global sexual and reproductive health and rights goals. The longstanding model of men neglecting or even sabotaging their wellbeing needs to be replaced by healthier lifestyles, which requires understanding how factors related to social support, social norms, power, academic performance or employability conditions, among others, influence men’s engagement with health services and with their own self care practices.


Author(s):  
Susan Igras ◽  
Marina Plesons ◽  
Venkatraman Chandra-Mouli

Abstract Over the past 25 years, there has been significant progress in increasing the recognition of, resources for, and action on adolescent health, and adolescent sexual and reproductive health (ASRH) in particular. As with numerous other health areas, however, many of the projects that aim to improve ASRH are implemented without well-thought-out plans for evaluation. As a result, the lessons that projects learn as they encounter and address policy and programmatic challenges are often not extracted and placed in the public arena. In such cases, post-project evaluation (PPE) offers the possibility to generate learnings about what works (and does not work), to complement prospective studies of new or follow-on projects. To fill the gap in the literature and guidance on PPE, the World Health Organization developed The project has ended, but we can still learn from it! Practical guidance for conducting post-project evaluations of adolescent sexual and reproductive health projects. This article provides an overview of the guidance by outlining key methodological and contextual challenges in conducting PPE, as well as illustrative solutions for responding to them.


BMC Medicine ◽  
2021 ◽  
Vol 19 (1) ◽  
Author(s):  
Sourya Shrestha ◽  
Emily A. Kendall ◽  
Rebekah Chang ◽  
Roy Joseph ◽  
Parastu Kasaie ◽  
...  

Abstract Background Global progress towards reducing tuberculosis (TB) incidence and mortality has consistently lagged behind the World Health Organization targets leading to a perception that large reductions in TB burden cannot be achieved. However, several recent and historical trials suggest that intervention efforts that are comprehensive and intensive can have a substantial epidemiological impact. We aimed to quantify the potential epidemiological impact of an intensive but realistic, community-wide campaign utilizing existing tools and designed to achieve a “step change” in the TB burden. Methods We developed a compartmental model that resembled TB transmission and epidemiology of a mid-sized city in India, the country with the greatest absolute TB burden worldwide. We modeled the impact of a one-time, community-wide screening campaign, with treatment for TB disease and preventive therapy for latent TB infection (LTBI). This one-time intervention was followed by the strengthening of the tuberculosis-related health system, potentially facilitated by leveraging the one-time campaign. We estimated the tuberculosis cases and deaths that could be averted over 10 years using this comprehensive approach and assessed the contributions of individual components of the intervention. Results A campaign that successfully screened 70% of the adult population for active and latent tuberculosis and subsequently reduced diagnostic and treatment delays and unsuccessful treatment outcomes by 50% was projected to avert 7800 (95% range 5450–10,200) cases and 1710 (1290–2180) tuberculosis-related deaths per 1 million population over 10 years. Of the total averted deaths, 33.5% (28.2–38.3) were attributable to the inclusion of preventive therapy and 52.9% (48.4–56.9) to health system strengthening. Conclusions A one-time, community-wide mass campaign, comprehensively designed to detect, treat, and prevent tuberculosis with currently existing tools can have a meaningful and long-lasting epidemiological impact. Successful treatment of LTBI is critical to achieving this result. Health system strengthening is essential to any effort to transform the TB response.


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